Autonomic Nervous SystemNCT02315482
Effect of Pneumoperitoneum and Steep Trendelenburg on Autonomic Nervous System
A study testing pneumoperitoneum insufflation and steep trendelenburg in people with Autonomic Nervous System, run by ASST Fatebenefratelli Sacco at 2 sites in Italy.
Trial summary
The purpose of this study is to assess the different effects of pneumoperitoneum and steep trendelenburg position on autonomic nervous system modulation during laparoscopic prostatectomy Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Autonomic Nervous System
- What is being tested?
- pneumoperitoneum insufflation and steep trendelenburg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males scheduled for elective laparoscopic prostatectomy
- sinus rhythm at electrocardiogram
- ectopic heart beats <5% of all heart beats
- american society of anesthesiologists status 1-3
Who cannot join
- autonomic dysfunction (documented or suspected)
- adrenal or thyroid dysfunction
- organ dysfunction secondary to diabetes (i.e. nephropathy, retinopathy, neuropathy)
- history of stroke, traumatic spinal injury, heart surgery or major vascular surgery
- intracranial hypertension (documented or suspected)
- hydrocephalus
Show all 10Show fewer
- New York Heart Association cardiac functional status ≥ IIb
- non sinusal heart rhythm
- ectopic heart beats ≥5% of normal heart beats
- therapy with beta-blockers or beta2-agonists
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Luigi Sacco Hospital
Milan, 20157
Istituto Clinico Humanitas
Rozzano, 20089
About this study
The purpose of this study is to assess the different effects of pneumoperitoneum and steep trendelenburg position on autonomic nervous system modulation during laparoscopic prostatectomy
Read the detailed description
Laparoscopic radical prostatectomy is becoming a widely used surgical procedure because it carries some important advantages over open prostatectomy. This surgical technique requires positioning the patient at 25-40 degree head-down position (steep trendelenburg) for a prolonged time in association with pneumoperitoneum at 12-15 mmHg. The postural change from supine to head down position causes a hydrostatic fluid shift towards the head and the thorax, thus increasing venous return and stimulating the cardiopulmonary baroreceptors. Moreover, there are reports of severe bradycardia and cardiac arrest following pneumoperitoneum in association with steep trendelenburg. A vagal hypertone induced by the combination of these two factors, or sympathetic hyperactivity elicited by pneumoperitoneum insufflation have been alternatively advocated as a cause of such hemodynamic changes. However these speculations are little more than a narrative role because any evidence based demonstration is never been provided.
The aim of this study is to measure the variations of autonomic nervous system modulation induced by steep trendelenburg position at 25 degrees and pneumoperitoneum during laparoscopic radical prostatectomy.
Methods Patients are randomized into two groups. Group A: after induction of general anesthesia, in supine position a pneumoperitoneum is induced with carbon dioxide insufflation through a surgical inserted trocar into the abdominal cavity, then patients are positioned in steep trendelenburg at 25 degrees head down. Group B: after induction of general anesthesia, patients are positioned in steep trendelenburg position at 25 degrees head down, then a pneumoperitoneum is induced with carbon dioxide insufflation through a surgical inserted trocar into the abdominal cavity.
Autonomic nervous system modulation is assessed at four main time: (i) T1 baseline (before the induction of general anesthesia); (ii) T2, 5 min after the induction of general anesthesia, (iii) T3, pneumoperitoneum insufflation (Group A) or steep trendelenburg (Group B); (iv) T4, steep trendelenburg (Group A) or pneumoperitoneum insufflation (Group B).
Autonomic nervous system modulation is studied non invasively by means of heart rate variability (HRV) analysis through both linear and non linear methods. Beat-to-beat intervals are computed detecting the QRS complex on the electrocardiogram and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition.
Linear HRV analysis The power spectrum is estimated according to a univariate parametric approach fitting the series to an autoregressive model. Autoregressive spectral density is factorized into components each of them characterized by a central frequency. A spectral component is labeled as LF if its central frequency is between 0.04 and 0.15 Hz, while it is classified as HF if its central frequency is between 0.15 and 0.4 Hz. The HF power of R-to-R series is utilized as a marker of vagal modulation directed to the heart , while the LF power of SAP series is utilized as a marker of sympathetic modulation directed to vessels. The ratio of the LF power to the HF power assessed from R-to-R series is taken as an indicator sympatho-vagal balance directed to the heart. Baroreflex control in the low frequencies is computed as the square root of the ratio of LF(RR) to LF(SAP). Similarly baroreflex control in the high frequencies is defined as the square root of the ratio of HF(RR) to HF(SAP).
Non linear HRV analysis The symbolic analysis is conducted on the same sequences of 300 consecutive heart beats used for the autoregressive analysis. The whole range of the R-to-R interval into each series is uniformly divided in 6 slices (symbols) and pattern of 3 consecutive heart beat intervals are considered. Thus each sequence of 300 heart beats has its own R-to-R range and 298 consecutive triplets of symbols. The Shannon entropy of the distribution of the patterns is calculated to provide a quantification of the complexity of the pattern distribution. All triplets of symbols are grouped into 3 possible patterns of variation: (i) no variation (0V, all 3 symbols were equal), (ii) 1 variation (1V, 2 consequent symbols were equal and the remaining symbol was different), (iii) patterns with at least 2 variations (2V, all symbols were different from the previous one). Previously, the percentage of 0V patterns was found to increase (and 2V decrease) in response to sympathetic stimuli, whereas 2V patterns increased (and 0V decreased) in response to vagal stimuli.
Researcher who analyzes the HRV is blinded to the patient's group assignment.
Management of general anesthesia is standardized as follows:
induction with propofol 1.5-2 mg/kg, Remifentanil Target Controlled Infusion (TCI) Ce 4 ng/ml , neuromuscular blockade with cisatracurium 0.2 mg/kg.
Maintenance: Sevoflurane 0.6-1.5 minimum alveolar concentration (State Entropy target: 40-60); Remifentanil TCI (range Ce 3-15 ng/ml).
mechanical ventilation at respiratory rate ≥14 breaths/min, with tidal volume adjusted to maintain end-tidal carbon dioxide at 32-38 mmHg, and airway plateau pressure <32 cmH2O.
Sample size:
to detect a difference in mean HF(RR) between groups at the trendelenburg positioning of 40 msec^2 with a standard deviation of 50 msec^2 with a power of 0.80 and type I error of 0.05, 26 patients are needed for each group.
- Conditions
- Autonomic Nervous System
- Being tested
- pneumoperitoneum insufflation and steep trendelenburg
- Keywords
- autonomic nervous system, heart rate variability, prostatectomy, steep trendelenburg, pneumoperitoneum, Intervention Affecting Autonomic Nervous System
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumoperitoneum insufflation and steep trendelenburgProcedure or surgery
the sequence of pneumoperitoneum insufflation and steep trendelenburg positioning is randomized
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | after induction of general anesthesia (i) a pneumoperitoneum is induced then (ii) patient is placed in steep trendelenburg position at 25 degrees head down Receives: Procedure: pneumoperitoneum insufflation and steep trendelenburg |
| Group B | Experimental | after induction of general anesthesia (i) the patient is placed in steep trendelenburg position at 25 degrees head down then (ii) a pneumoperitoneum is induced Receives: Procedure: pneumoperitoneum insufflation and steep trendelenburg |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg
changes of autonomic nervous system activity independently elicited by (i) pneumoperitoneum and (ii) steep trendelenburg position. The High Frequency and Low Frequency spectral power of beat-to-beat heart intervals will be assessed with autoregressive analysis and expressed in msec^2
Measured: 60 min
Secondary outcomes (1)
changes of symbolic patterns induced by pneumoperitoneum and steep trendelenburg
changes of autonomic nervous system activity independently elicited by (i) pneumoperitoneum and (ii) steep trendelenburg position. The autonomic nervous activity will be analyzed by means of symbolic analysis of beat-to-beat heart intervals and expressed as percentage of triplets
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Collaborators
- Andrea Marchi, Ferdinando Raimondi, Alberto Porta, Stefano Guzzetti, Tommaso Fossali
- Responsible party
- Principal investigator, Riccardo Colombo, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315482
- Sponsor's protocol ID
- Prostate2
- Status last verified
- Jun 2015
- First submitted
- 24 Nov 2014
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2. doi: 10.1126/science.6166045.
PubMed 6166045Charkoudian N, Martin EA, Dinenno FA, Eisenach JH, Dietz NM, Joyner MJ. Influence of increased central venous pressure on baroreflex control of sympathetic activity in humans. Am J Physiol Heart Circ Physiol. 2004 Oct;287(4):H1658-62. doi: 10.1152/ajpheart.00265.2004. Epub 2004 Jun 10.
PubMed 15191897Deutschman CS, Harris AP, Fleisher LA. Changes in heart rate variability under propofol anesthesia: a possible explanation for propofol-induced bradycardia. Anesth Analg. 1994 Aug;79(2):373-7. doi: 10.1213/00000539-199408000-00031.
PubMed 7639382Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
PubMed 18200624Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.
PubMed 19185977Gainsburg DM, Wax D, Reich DL, Carlucci JR, Samadi DB. Intraoperative management of robotic-assisted versus open radical prostatectomy. JSLS. 2010 Jan-Mar;14(1):1-5. doi: 10.4293/108680810X12674612014266.
PubMed 20529522Harrison MH, Rittenhouse D, Greenleaf JE. Effect of posture on arterial baroreflex control of heart rate in humans. Eur J Appl Physiol Occup Physiol. 1986;55(4):367-73. doi: 10.1007/BF00422735.
PubMed 3758036Hu JC, Gu X, Lipsitz SR, Barry MJ, D'Amico AV, Weinberg AC, Keating NL. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009 Oct 14;302(14):1557-64. doi: 10.1001/jama.2009.1451.
PubMed 19826025Guzzetti S, Borroni E, Garbelli PE, Ceriani E, Della Bella P, Montano N, Cogliati C, Somers VK, Malliani A, Porta A. Symbolic dynamics of heart rate variability: a probe to investigate cardiac autonomic modulation. Circulation. 2005 Jul 26;112(4):465-70. doi: 10.1161/CIRCULATIONAHA.104.518449. Epub 2005 Jul 18.
PubMed 16027252Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.
PubMed 7923668
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pneumoperitoneum and Steep Trendelenburg on Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT02315482
- Acronym / sponsor ID
- Prostate2
- Conditions
- Autonomic Nervous System
- Keywords
- autonomic nervous system, heart rate variability, prostatectomy, steep trendelenburg, pneumoperitoneum, Intervention Affecting Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Collaborators
- Andrea Marchi, Ferdinando Raimondi, Alberto Porta, Stefano Guzzetti, Tommaso Fossali
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the different effects of pneumoperitoneum and steep trendelenburg position on autonomic nervous system modulation during laparoscopic prostatectomy
Detailed description
Laparoscopic radical prostatectomy is becoming a widely used surgical procedure because it carries some important advantages over open prostatectomy. This surgical technique requires positioning the patient at 25-40 degree head-down position (steep trendelenburg) for a prolonged time in association with pneumoperitoneum at 12-15 mmHg. The postural change from supine to head down position causes a hydrostatic fluid shift towards the head and the thorax, thus increasing venous return and stimulating the cardiopulmonary baroreceptors. Moreover, there are reports of severe bradycardia and cardiac arrest following pneumoperitoneum in association with steep trendelenburg. A vagal hypertone induced by the combination of these two factors, or sympathetic hyperactivity elicited by pneumoperitoneum insufflation have been alternatively advocated as a cause of such hemodynamic changes. However these speculations are little more than a narrative role because any evidence based demonstration is never been provided.
The aim of this study is to measure the variations of autonomic nervous system modulation induced by steep trendelenburg position at 25 degrees and pneumoperitoneum during laparoscopic radical prostatectomy.
Methods Patients are randomized into two groups. Group A: after induction of general anesthesia, in supine position a pneumoperitoneum is induced with carbon dioxide insufflation through a surgical inserted trocar into the abdominal cavity, then patients are positioned in steep trendelenburg at 25 degrees head down. Group B: after induction of general anesthesia, patients are positioned in steep trendelenburg position at 25 degrees head down, then a pneumoperitoneum is induced with carbon dioxide insufflation through a surgical inserted trocar into the abdominal cavity.
Autonomic nervous system modulation is assessed at four main time: (i) T1 baseline (before the induction of general anesthesia); (ii) T2, 5 min after the induction of general anesthesia, (iii) T3, pneumoperitoneum insufflation (Group A) or steep trendelenburg (Group B); (iv) T4, steep trendelenburg (Group A) or pneumoperitoneum insufflation (Group B).
Autonomic nervous system modulation is studied non invasively by means of heart rate variability (HRV) analysis through both linear and non linear methods. Beat-to-beat intervals are computed detecting the QRS complex on the electrocardiogram and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition.
Linear HRV analysis The power spectrum is estimated according to a univariate parametric approach fitting the series to an autoregressive model. Autoregressive spectral density is factorized into components each of them characterized by a central frequency. A spectral component is labeled as LF if its central frequency is between 0.04 and 0.15 Hz, while it is classified as HF if its central frequency is between 0.15 and 0.4 Hz. The HF power of R-to-R series is utilized as a marker of vagal modulation directed to the heart , while the LF power of SAP series is utilized as a marker of sympathetic modulation directed to vessels. The ratio of the LF power to the HF power assessed from R-to-R series is taken as an indicator sympatho-vagal balance directed to the heart. Baroreflex control in the low frequencies is computed as the square root of the ratio of LF(RR) to LF(SAP). Similarly baroreflex control in the high frequencies is defined as the square root of the ratio of HF(RR) to HF(SAP).
Non linear HRV analysis The symbolic analysis is conducted on the same sequences of 300 consecutive heart beats used for the autoregressive analysis. The whole range of the R-to-R interval into each series is uniformly divided in 6 slices (symbols) and pattern of 3 consecutive heart beat intervals are considered. Thus each sequence of 300 heart beats has its own R-to-R range and 298 consecutive triplets of symbols. The Shannon entropy of the distribution of the patterns is calculated to provide a quantification of the complexity of the pattern distribution. All triplets of symbols are grouped into 3 possible patterns of variation: (i) no variation (0V, all 3 symbols were equal), (ii) 1 variation (1V, 2 consequent symbols were equal and the remaining symbol was different), (iii) patterns with at least 2 variations (2V, all symbols were different from the previous one). Previously, the percentage of 0V patterns was found to increase (and 2V decrease) in response to sympathetic stimuli, whereas 2V patterns increased (and 0V decreased) in response to vagal stimuli.
Researcher who analyzes the HRV is blinded to the patient's group assignment.
Management of general anesthesia is standardized as follows:
induction with propofol 1.5-2 mg/kg, Remifentanil Target Controlled Infusion (TCI) Ce 4 ng/ml , neuromuscular blockade with cisatracurium 0.2 mg/kg.
Maintenance: Sevoflurane 0.6-1.5 minimum alveolar concentration (State Entropy target: 40-60); Remifentanil TCI (range Ce 3-15 ng/ml).
mechanical ventilation at respiratory rate ≥14 breaths/min, with tidal volume adjusted to maintain end-tidal carbon dioxide at 32-38 mmHg, and airway plateau pressure <32 cmH2O.
Sample size:
to detect a difference in mean HF(RR) between groups at the trendelenburg positioning of 40 msec^2 with a standard deviation of 50 msec^2 with a power of 0.80 and type I error of 0.05, 26 patients are needed for each group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: pneumoperitoneum insufflation and steep trendelenburgafter induction of general anesthesia (i) a pneumoperitoneum is induced then (ii) patient is placed in steep trendelenburg position at 25 degrees head down |
| Group B | Experimental | Procedure: pneumoperitoneum insufflation and steep trendelenburgafter induction of general anesthesia (i) the patient is placed in steep trendelenburg position at 25 degrees head down then (ii) a pneumoperitoneum is induced |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males scheduled for elective laparoscopic prostatectomy
- sinus rhythm at electrocardiogram
- ectopic heart beats <5% of all heart beats
- american society of anesthesiologists status 1-3
Key exclusion criteria (10 listed)
- autonomic dysfunction (documented or suspected)
- adrenal or thyroid dysfunction
- organ dysfunction secondary to diabetes (i.e. nephropathy, retinopathy, neuropathy)
- history of stroke, traumatic spinal injury, heart surgery or major vascular surgery
- intracranial hypertension (documented or suspected)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumoperitoneum insufflation and steep trendelenburgthe sequence of pneumoperitoneum insufflation and steep trendelenburg positioning is randomized | Procedure or surgery | Group A, Group B |
Primary outcome
changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg
Time frame: 60 min
changes of autonomic nervous system activity independently elicited by (i) pneumoperitoneum and (ii) steep trendelenburg position. The High Frequency and Low Frequency spectral power of beat-to-beat heart intervals will be assessed with autoregressive analysis and expressed in msec^2
1 secondary outcome
changes of symbolic patterns induced by pneumoperitoneum and steep trendelenburg
Time frame: 60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Background: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Background: PubMed 6166045Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2. doi: 10.1126/science.6166045.
- Background: PubMed 15191897Charkoudian N, Martin EA, Dinenno FA, Eisenach JH, Dietz NM, Joyner MJ. Influence of increased central venous pressure on baroreflex control of sympathetic activity in humans. Am J Physiol Heart Circ Physiol. 2004 Oct;287(4):H1658-62. doi: 10.1152/ajpheart.00265.2004. Epub 2004 Jun 10.
- Background: PubMed 7639382Deutschman CS, Harris AP, Fleisher LA. Changes in heart rate variability under propofol anesthesia: a possible explanation for propofol-induced bradycardia. Anesth Analg. 1994 Aug;79(2):373-7. doi: 10.1213/00000539-199408000-00031.
- Background: PubMed 18200624Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
- Background: PubMed 19185977Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.
- Background: PubMed 20529522Gainsburg DM, Wax D, Reich DL, Carlucci JR, Samadi DB. Intraoperative management of robotic-assisted versus open radical prostatectomy. JSLS. 2010 Jan-Mar;14(1):1-5. doi: 10.4293/108680810X12674612014266.
- Background: PubMed 3758036Harrison MH, Rittenhouse D, Greenleaf JE. Effect of posture on arterial baroreflex control of heart rate in humans. Eur J Appl Physiol Occup Physiol. 1986;55(4):367-73. doi: 10.1007/BF00422735.
- Background: PubMed 19826025Hu JC, Gu X, Lipsitz SR, Barry MJ, D'Amico AV, Weinberg AC, Keating NL. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009 Oct 14;302(14):1557-64. doi: 10.1001/jama.2009.1451.
- Background: PubMed 16027252Guzzetti S, Borroni E, Garbelli PE, Ceriani E, Della Bella P, Montano N, Cogliati C, Somers VK, Malliani A, Porta A. Symbolic dynamics of heart rate variability: a probe to investigate cardiac autonomic modulation. Circulation. 2005 Jul 26;112(4):465-70. doi: 10.1161/CIRCULATIONAHA.104.518449. Epub 2005 Jul 18.
- Background: PubMed 7923668Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumoperitoneum insufflation and steep trendelenburg in people with Autonomic Nervous System, run by ASST Fatebenefratelli Sacco at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315482, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.